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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
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Sandra “SAM” Sather will be speaking at the Society of Quality Assurance (SQA) September Virtual Meeting and Quality College on the topics:
Quality Risk Management Not an Option, But A Mindset, What Are We Learning During COVID-19
Remote Operations and Maintaining HIPAA, GDPR, GCP, and COVID-19
When: September 21 and 22, 2020
Where: Virtual
Schedule: HERE
Register: HERE
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When: September 17, 2020
Time: Live from 1-2 PM EDT
Register: HERE
Released in July 2020, ISO 14155:2020 is the third version of the standards that provides direction on how to implement GCP for medical device clinical investigations. The changes in this revision are designed to ensure that ISO standards are up to date with regulatory changes in the industry.
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On April 7, 2020, the European Medicines Agency (EMA) released a Notice to sponsors on validation and qualification of computerized systems used in clinical trials. This guidance is applicable for clinical trials conducted in the EU and clarifies that even though a sponsor may delegate all or part of clinical trial activities out to a company, the ultimate responsibility for validation of software tools or electronic systems remains with the sponsor. This guidance also clarifies that most vendors focus on system security of the participant’s personal data, but they lack a focus on how an electronic system used in a clinical trial must comply with Good Clinical Practice (GCP) and the documentation principles of ALCOA+.
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Sandra “SAM” Sather, VP of Clinical Pathways and a 2020 MCC Ambassador, is speaking on the topic “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb”. Have you heard "We are not doing RBM for this study . . ." What? Our quality system should support a risk-based approach to many clinical trial activities like site monitoring, data quality oversight, vendor oversight, safety surveillance, audit planning, and more.
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The Food and Drug Administration (FDA) released a final guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” It clarifies how the FDA determines the “responsible parties” have submitted registration information when required, that the information submitted is factual, and when noncompliance results in civil money penalties.
